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CDSCO’s Dual Role as Regulator and Prosecutor: Structural Conflict of Interest and Reform Proposals
ABSTRACT The Central Drugs Standard Control Organisation (CDSCO) occupies an unusual institutional position in India’s regulatory landscape: it is simultaneously the authorit
Compounding of Offences Under the Drugs and Cosmetics Act: The 2025 Rules and Their Interface with Prosecution
ABSTRACT The Drugs and Cosmetics (Compounding of Offences) Rules, 2025, notified on April 24, 2025 under Sections 32B and 33(2)(r) of the Drugs and Cosmetics Act, 1940, represent a
Can CDSCO Ignore Its Own Prosecution Guidelines? Legal Validity and Article 14 Challenge Explained
ABSTRACT The DCC and CDSCO prosecution guidelines are not legally binding as a matter of positive law — they cannot override the strict liability provisions of the Drugs and Cosm
Section 26A of the Drugs and Cosmetics Act, 1940: India’s Sharpest Drug Regulatory Instrument
ABSTRACT Section 26A of the Drugs and Cosmetics Act, 1940 empowers the Central Government to prohibit the manufacture, sale, or distribution of any drug in the public interest by n
The Mandatory Procedure for a Drug Inspector’s Complaint Under the Drugs and Cosmetics Act, 1940
ABSTRACT The Drugs and Cosmetics Act, 1940 establishes a unique prosecution architecture: criminal proceedings for quality offences can be initiated only through a complaint, not t
Section 119 IT Act vs Section 7 D&C Act: Why CBDT Circulars Are Binding in Nature But DCC Guidelines Are Not
ABSTRACT Two of India’s most prominent regulatory bodies — the Central Board of Direct Taxes (CBDT) and the Drugs Consultative Committee (DCC) — issue prosecution-related gui
DCC Prosecution Guidelines Under the Drugs and Cosmetics Act, 1940: An Ultra Vires Analysis
ABSTRACT The Drugs Consultative Committee (DCC), constituted under Section 7 of the Drugs and Cosmetics Act, 1940, periodically issues guidelines classifying drug quality defects i
CDSCO India: Drug Approval Process, Licensing & Compliance Framework
Introduction to CDSCO The pharmaceutical industry in India is a complex and rapidly evolving sector, playing a crucial role in global healthcare. At the heart of regulating this va
